510(k) K143586
K143586 is an FDA 510(k) premarket notification submitted by Dexin Medical Imaging Technology Co., Ltd. for the device "FACT Medical Imaging Sysytem". The FDA issued a decision of Substantially Equivalent on Sep 2, 2015. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 2, 2015
- Date Received
- Dec 18, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)